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Study on the Effectiveness and Safety of HRO350 for Patients with Mild-to-Moderate Psoriasis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for psoriasis, a skin condition that causes red, itchy, and scaly patches. The treatment being tested is called HRO350, which contains a substance known as PEHeRo (phospholipid esters from herring roe oil). The study will compare the effects of two different doses of HRO350 to a placebo in people with mild-to-moderate psoriasis. The goal is to find the most effective dose for future studies.

Participants in the study will take the treatment in the form of soft capsules by mouth. The study will last for several weeks, during which participants will be monitored to see how their psoriasis responds to the treatment. The study will also look at the safety of the treatment and any side effects that may occur. Throughout the study, participants will have regular check-ups to assess their skin condition and overall health.

In addition to HRO350, the study will also involve the use of betamethasone valerate, a common ointment used to treat skin inflammation, as part of the treatment process. The study aims to provide valuable information on the effectiveness and safety of HRO350, helping to determine the best dose for future research and potential use in treating psoriasis. Participants will be closely monitored to ensure their safety and well-being throughout the study.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
<b>participation</b> in the study
The trial begins with the administration of an oral medication or a placebo, which is a substance that contains no active medicine. you will be assigned to one of three groups to receive either pehero at a dose of 1050 mg daily, pehero at a dose of 2100 mg daily, or a placebo.
During this period, betamethasone valerate, a topical cream (applied to the skin), will be used as a background treatment.
Step 2
<b>treatment period</b>
The treatment phase continues for a total of 26 weeks.
The goal of this stage is to monitor the efficacy, which refers to how well the medicine works to reduce psoriasis symptoms, and to ensure safety through various assessments.

Who can join the trial?

9 criteria

You must provide a signed and dated informed consent, which is a document where you agree to participate in the study after being told about all its details.
You must be male or female and at least 18 years of age.
You must have been diagnosed with chronic, active plaque psoriasis, which is a long-term skin condition that causes raised, red, and scaly patches, and this condition must be mild to moderate in severity.
Your psoriasis must have continued for at least 6 months without using systemic treatment, which refers to medications that work throughout your entire body rather than just on the skin surface.
Your Psoriasis Area and Severity Index (PASI) score, which is a tool used to measure how much skin is covered and how severe the symptoms are, must be between 3 and 10.
Your Body Surface Area (BSA), which is the measurement of how much of your total body skin is affected by the condition, must be at least 3.
Your Static Physician’s Global Assessment (sPGA) score, which is a scale used by a doctor to rate the overall severity of your skin condition, must be between 2 and 4.
Men and women who are able to have children must agree to use highly effective birth control, such as implants, certain pills, or devices placed in the uterus, throughout the study and for 30 days after finishing the treatment.
Women will be considered to have the potential to have children unless they have had surgery to prevent pregnancy, such as a hysterectomy (removal of the uterus) or tubal ligation (closing the fallopian tubes), or if they have not had a period for at least 12 months due to menopause.

Who cannot join the trial?

7 criteria

You cannot participate if you have used phototherapy, which is a treatment that uses ultraviolet radiation (light rays from the sun or special lamps) to treat skin conditions, within 8 weeks before the study starts or during the study.
You cannot participate if you have taken any investigational drug, which is a medicine that is currently being tested in a clinical trial, within 4 weeks before the study starts or during the study.
You cannot participate if you have used systemic anti-psoriatic treatment, which are medicines that work throughout your entire body to treat psoriasis, within the last 3 months before the study starts or during the study. For biologics, which are specific types of medicines made from living organisms to target certain parts of the immune system, this period is 6 months.
You cannot participate if you have used topical anti-psoriatic treatment, which are creams, ointments, or gels applied directly to the skin, within the last 2 weeks before the study starts.
You cannot participate if you have changed any anti-inflammatory medication, which are drugs used to reduce swelling and pain for other long-term illnesses, within the last 4 weeks before the study starts or during the study.
You cannot participate if you have taken omega-3 fatty acid supplements or medicines, which are nutrients often found in fish oil, within the last 2 weeks before the study starts or during the study.
You cannot participate if you have a known allergy, which is an immune system reaction, to fish or vegetable oils such as soy.

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Verified sites

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Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Verified
Mainz, Germany
Clinical Research Services Turku CRST Oy
Verified
Turku, Finland
Universitetssykehuset Nord-Norge HF
Responsive
Tromsø, Norway

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Investigated drugs

Pehero
is an oral medication being tested to see how well it works and how safe it is for people living with mild-to-moderate psoriasis.
Betamethasone valerate
is a topical cream used as background therapy to help manage skin symptoms.

What is already known about the treatment

Betamethasone valerate
This medication is applied directly to the skin as a cream or ointment to treat various skin conditions. It is a well-established steroid used to reduce redness, swelling, and itching caused by inflammation. At a molecular level, it works by calming the immune system and decreasing the production of chemicals that cause inflammation in the body. It is classified as a topical corticosteroid.
Pehero
This is an experimental medication being studied in clinical trials and is currently taken orally in the form of soft capsules. It is being investigated for its ability to treat skin conditions like psoriasis. The drug works by targeting specific biological processes in the body to reduce the overactive immune response that causes skin lesions. It is classified as an investigational therapeutic agent.

Investigated diseases

Psoriasis - This is a chronic condition that affects the skin by causing cells to multiply much faster than normal. These excess skin cells build up on the surface, forming thick, red, and scaly patches. The affected areas can appear on various parts of the body, such as the elbows, knees, or scalp. As the condition progresses, these patches may become itchy, sore, or cracked. The appearance and severity of these skin changes can fluctuate over time.